Track-and-trace provision missing from pharma law

Thursday, June 28, 2012

Congress passed the Food and Drug Administration Safety and Innovation Act this week, but did not include a provision aimed at improving supply chain safety.
Among other things, the legislation will "for the first time, enable the FDA to: regularly inspect foreign drug manufacturing facilities, which supply 80 percent of the ingredients in our medications," said Allan Coukell, director of medical programs at the Pew Health Group.
But UPS spokesman Kara Gerhardt Ross said "a very important safety proposal that was close to agreement did not get included in the final bill. The 'track and trace proposal,' supported by PDSA (Pharmaceutical Distribution Security Alliance) would have provided a bipartisan national 50-state solution to supply chain safety for medicines. The current patchwork of state regulations and varying individual license requirements is an impediment to law enforcement and protecting patients."
Ross added: "A national system would help to ensure safe passage of drugs and medical products across the U.S. and address the growing problem of counterfeit drugs through the complex network of manufacturers, wholesalers, third party logistics providers and pharmacies."